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Last Updated: June 3, 2023

Regulatory Exclusivity: NEW CHEMICAL ENTITY

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Drugs with New Chemical Entity Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Allergan	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes	⤷ Try a Trial	NEW CHEMICAL ENTITY
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	⤷ Try a Trial	NEW CHEMICAL ENTITY
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	⤷ Try a Trial	NEW CHEMICAL ENTITY
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Try a Trial	NEW CHEMICAL ENTITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Colorcon

Boehringer Ingelheim

Express Scripts

Merck

Baxter

McKesson

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